Method and device for simultaneously documenting and treating tension pneumothorax and/or hemothorax

ABSTRACT

A method and device are provided for simultaneously or near-simultaneously diagnosing and treating tension pneumothorax and/or hemothoraxA Veress-type needle portion includes a hollow needle for puncturing the chest wall over a blunt hollow probe biased by one or more springs to extend distally into the pleural cavity. Openings in the blunt hollow probe connect via a pathway to an automatic check valve, which permits the flow of air and/or fluid only in a proximal direction. Pressure from within the pleural cavity is transmitted to the interior surface of a pressure documenter. If pressure greater than atmospheric pressure is present in the pleural cavity, the pressure documenter will be automatically urged proximally to simultaneously allow air and/or fluid to escape from the pleural space through the device, thus treating the tension pneumothorax and/or hemothorax, as well as providing a stable indicator to positively document the diagnosis of increased pressure.

RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.13/961,422 filed Aug. 7, 2013, which claims the benefit of U.S.Provisional Application No. 61/680,505 filed Aug. 7, 2012, which isincorporated herein in its entirety by reference.

FIELD OF THE INVENTION

The present invention relates to devices and methods for treatingpatients suffering from closed tension pneumothorax and/or hemothorax.In particular, the present invention relates to devices and methods fortreating patients suffering from tension pneumothorax and/or hemothoraxthat substantially reduce the possibility of iatrogenic lung punctureand/or introduction of air into the pleural space, while swiftlyallowing for the simultaneous documentation and treatment of theselife-threatening conditions.

BACKGROUND OF THE INVENTION

Normally, the lungs are kept inflated within the chest cavity bynegative pressure in the pleural spaces. A lung will partially orcompletely collapse if air and/or blood collects in the pleural space,thus causing loss of negative pressure (termed pneumothorax and/orhemothorax respectively). The most dangerous type of these conditions istension pneumothorax (i.e. pressure pneumothorax or valve pneumothorax)and/or, less commonly, tension hemothorax. In this case, the lung notonly fully collapses, but the air and/or fluid within the pleural spacebuilds up enough pressure in the chest cavity to cause a significantdecrease in the ability of the body's veins to return blood to theheart, which can result in cardiac arrest and death unless treatedemergently.

Tension pneumothorax and/or hemothorax is the second leading cause (33%)of potentially preventable combat deaths and constitutes around 5% ofall fatal military injuries. In addition to penetrating and blasttrauma, tension pneumothorax can also occur from other forms ofbarotrauma, such as high pressures during mechanical ventilation,underlying lung disease (e.g. asthma, emphysema, blebs), changes inenvironmental pressure (e.g. hyperbaric treatment, high-altitude, rapidascent from scuba diving), and/or Cardio-Pulmonary Resuscitation (CPR).Studies on ICU deaths show rates of undiagnosed tension pneumothoraxranging from 1.1% to 3.8%, with increased risk for patients who hadventilation or cardiopulmonary resuscitation. Early diagnosis and swifttreatment of tension pneumothorax and/or hemothorax, by relieving thepressure in the pleural space, is critical for patient survival.However, correct diagnosis of this condition is far from guaranteedduring emergencies. Presentation of the classic signs and symptoms arehighly variable and, in many cases, the time and/or treatmentenvironment does not permit diagnostic confirmation by chest x-ray,ultrasound, or other means. Thus, current treatments may be withheld dueto fear of causing patient harm or, conversely, may be inadvertentlyperformed on a healthy lung and worsen the patient's condition.

Traditional treatment, especially in the out-of-hospital emergencyarena, is to place a wide-bore needle and plastic cannula into the chestcavity to release pressure (i.e. “needle thoracostomy” or “chestdecompression”). For example, current Tactical Combat Casualty Careguidelines recommend the consideration of this “needle decompression” incasualties with chest trauma and progressive respiratory distress.Simple wide-bore needles for this use are widely available commercially.Examples include standard IV catheters in various sizes (e.g. from BDAngiocath™) and the “H&H Tension Pneumothorax Needle” from H&HAssociates, Inc. However, although standard needle decompression is aneffective treatment for pressure buildup, it has multiple disadvantages.Such treatment results in lung compromise, as an open passage is left inthe chest wall producing a non-tension open pneumothorax; possibleiatrogenic injury to the lung or heart, from introduction of the sharpneedle tip; the necessity of all patients having subsequent tubethoracostomy (a major procedure), upon presentation to a higher level ofcare; and, inability to perform the technique bilaterally, withoutsubsequent continuous positive pressure ventilation (because both lungsare deflated).

Some authors have discussed solutions for individual improvements uponthis simple needle thoracostomy technique, including the use of asyringe filled with sterile saline attached to the cannula or the“hanging drop” technique to help confirm pleural penetration; anAsherman chest seal to stabilize the cannula and provide a check valve;or, the attachment of a flutter valve to the cannula to decrease thechances of iatrogenic pneumothorax (e.g. Cook® Emergency Pneumothorax,Pre-Hospital Emergency Pneumothorax, and Spec Ops Emergency PneumothoraxSets). However, these advances all have individual drawbacks, takeadditional steps and equipment, and are not common in actual use.

The literature discloses various additional known methods and devicesrelated to the treatment of tension pneumothorax and/or hemothorax.

For example, U.S. Pat. No. 2012/0051967 A1 to Murphy et al describes abattlefield needle container for carrying a standard needle to be usedfor treating tension pneumothorax and/or hemothorax. However, thisdevice has no improvements upon the needle device itself.

U.S. Pat. No. 5,478,333 to Asherman, Jr. discloses a medical dressingfor treatment of open chest injuries. The device consists of a dressingmade of pliable plastic placed over an open wound, having a check valveto allow built up pressure to vent. Similar devices and procedures areset forth in U.S. Pat. No. 7,429,687 B2 to Kauth et al, U.S. Pat. No.7,615,674 B2 to Asherman, and 2011/0054340 to Russ et al. Although theseand similar works are capable of preventing the conversion of an openpneumothorax to a tension pneumothorax, all such devices are incapableof treating a closed tension pneumothorax, as they have no means topenetrate the chest and allow the built up pressure to vent.Additionally, when used over a standard needle, they have multipledisadvantages including a multi-step process, which at the minimumresults in a transient open pneumothorax, as well as the lack of anydocumentation means.

U.S. Pat. No. 4,164,938 to Higaki, et al describes a simple one-stagedevice for the diagnosis of tension pneumothorax. This work describes astandard needle attached to a balloon; when inserted into the pleuralspace, the balloon inflates if there is increased pressure, transientlyindicating tension. However, although this medical pressure-gauge devicecan diagnose tension pneumothorax, it is not a treatment device as noair (besides that inside the balloon) is actually released from thebody. Additionally, it has the added disadvantage of a sharp distalneedle end, which may potentially injure the lung.

U.S. Pat. No. 4,153,058 to Nehme discloses a pleural decompressioncatheter for releasing entrapped air within a human body. The deviceconsists of an elongated prong inserted into the chest, having a passagefor establishing communication from the pleural space, through a one-wayballoon valve, to the external environment. Once the device is insertedinto the patient, the trocar is removed to release trapped air. However,this device, as well as a similar one disclosed in U.S. Pat. No.4,664,660 to Goldberg et al, has numerous disadvantages for the emergenttreatment of tension pneumothorax and/or hemothorax. The size andcomplexity of these devices render them ill-suited for use in emergencysituations. Additionally, both devices are placed over a trocar,necessitating a multi-step process for treatment. They additionally haveno means to affix to the patient, in case of transport, and have nodocumentation means, to alert later caregivers that tension had (or hadnot) previously been present. Additionally, both have sharp distal endswhich may injure the lung upon initial placement, especially if apneumothorax and/or hemothorax was incorrectly diagnosed.

U.S. Pat. No. 7,229,433 to Mullen describes an apparatus specificallyfor treating pneumothorax and/or hemothorax. This involves theintroduction of a catheter with a check valve over a large trocarobturator unit, along with a means of securely affixing the catheter tothe patient. However, this device has similar disadvantages, includingthe risk of lung injury upon introduction of the trocar into the chestcavity, especially if a pneumothorax and/or hemothorax was incorrectlydiagnosed. Furthermore, the device requires a multi-step process fortreatment (adding complexity and delay) and lacks a diagnosticdocumentation indicator to alert current and later caregivers of thediagnosis.

U.S. Pat. No. 6,402,770 to Jessen describes a method and apparatus forplacing a tube into the body that can also be used for the treatment ofpneumothorax and/or hemothorax. It utilizes a cam action dual-bladethoracostomy device that additional has a check valve component.However, this device has the disadvantage of possible injury to thechest wall neurovascular structures, the lung, and other organs throughthe use of moving blades. It also lacks a diagnostic documentationindicator.

Similarly, U.S. Pat. Application No. 2008/0312638 and U.S. Pat. No.8,057,443 B2 to McNeil describe an apparatus for withdrawing fluidand/or air from a space in the body that could be used for treatment oftension pneumothorax. The work includes a catheter that is placed over ahollow needle into the pleural space with means for affixing said deviceto the patient and withdrawing air and/or fluid. However, this devicehas similar disadvantages for the emergency treatment of pneumothoraxand/or hemothorax, including the aforementioned disadvantages toMullen's as well as the lack of an automatic check valve.

Similarly, U.S. Pat. No. 4,944,724 to Goldberg, et al describes anapparatus for locating a body cavity having a fluctuating fluidpressure, such as fluid in the pleural space. The work includes acatheter that is placed over a hollow trocar with a pressure bubbleindicator, to allow for visualization of changes in pressure whileplacing the needle, and a means for affixing the device to the patient.However, the apparatus is not fashioned specifically for the emergenttreatment of tension pneumothorax and/or hemothorax, and thus hasmultiple disadvantages for this indication. The device overall is bulkyand requires a multi-step introduction of a sharp trocar, which maypotentially injure the lung. Furthermore, its indicator is transient anddoes not leave stable documentation of tension for later caregivers toview.

Additionally, U.S. Pat. No. 6,770,070 to Balbierz describes a method andapparatus for the prevention of pneumothorax during lung biopsy, whichcan seal lacerations in the lung. However, this device is not for theemergent treatment of tension pneumothorax and/or hemothorax.

Also known in the art are “Veress” or “Veress-type” needles, which havean outer needle having a sharp distal end and an inner probe with ablunt distal end that extends through the outer needle. In Veressneedles, the inner probe is biased to force the blunt distal end of theprobe beyond the sharp distal end of the outer needle. This thenprevents injury to internal organs (e.g. lung). However, when the bluntdistal end of the probe encounters dense material (e.g. chest wall), theprobe is forced backward, and the sharp end of the needle is presentedso that it can puncture the dense material.

Most Veress needles in the art describe use primarily for abdominallaparoscopic procedures, such as U.S. Pat. Nos. 5,376,082; 5,207,647;5,514,111; 5,827,221; and 6,221,048 to Phelps; U.S. Pat. No. 5,660,883to Scarfone, et al; 2009/0005800 to Franer et al, and U.S. Pat. No.5,098,388 to Kulkashi et al. These are not adapted for the emergenttreatment of pneumothorax and/or hemothorax and thus have multipledisadvantages in being modified to do so, including being overly largeand bulky for emergency use, lacking an automatic check valve to preventintroduction of external air, and the absence of a documentationindicator to alert later caregivers that tension of pneumothorax and/orhemothorax had previously been treated and thus necessitating furthercare.

Similarly, U.S. Pat. No. 5,421,821 to Janicki et al describes a Veressneedle system and method for insufflating the abdominal cavity prior tolaparoscopic surgery. This system includes an electronic sensor todetect negative pressure and indicate when the surgeon enters theabdominal cavity. However, this device is not adapted for the emergentdiagnosis and treatment of pneumothorax and/or hemothorax. It lacks anautomatic check valve to prevent introduction of external air and has nomeans to affix to the device to the patient. Additionally, theelectronic pressure indicator described only indicates negative (notpositive “tension”) pressure and is a transient (not stable) indicator.

U.S. Pat. No. 5,300,046 to Scarfone, et al; U.S. Pat. No. 5,997,486 toBurek, et al; and, U.S. Pat. No. 5,725,506 to Freeman, et al describessimilar devices and methods for thoracentesis; a Veress needle insertedinto the pleural space is used to introduce a catheter for drainage.Although these devices could be used to relieve a tension pneumothorax,they have multiple disadvantages in the emergent setting including theneed for a multi-step process requiring withdrawal of the needle from acatheter and the lack of a stable documentation indicator, to alertlater caregivers that tension pneumothorax and/or hemothorax hadpreviously been treated thus necessitating further care.

U.S. Pat. No. 5,334,159 to Turkel describes a Veress thoracentesisneedle having a direct passageway through the needle for withdrawingfluid (no overlying catheter) and an automatic check valve to preventintroduction of air into the pleural space. Although this device is asignificant improvement over prior art, it is fashioned for standardpleural fluid withdrawal, not for the emergent treatment of tensionpneumothorax and/or hemothorax. Thus it has multiple disadvantages inbeing used for the later indication in the emergency arena. Thisincludes the absence of a diagnostic documentation indicator to alertlater caregivers that a tension pneumothorax had been treated prior toarrival. If this device was used in an out-of-hospital emergency (e.g.in an ambulance or battlefield), the only way of knowing that a tensionpneumothorax had been treated would be by the out-of-hospital providerhearing a short “whish” of air out of the needle, something that can bevery subjective and difficult to hear in a loud out-of-hospitalenvironment with possible sirens and/or gunfire. Thus, without thestable indicator, each patient that had needle decompression performedin the field (whether or not they truly had a tension pneumothorax atthat time) would likely need a full chest tube thoracostomy upon arrivalto higher care. This is because both patients who actually had a tensionpneumothorax and those who had been misdiagnosed could both have thesame diagnostic findings upon later chest x-ray or ultrasound (i.e. a(re)inflated lung due to the automatic check valve venting air). Thus,it is dangerous to remove the device without placing a full chest tubeas tension pneumothorax could rapidly return.

Turkel also describes no means to affix the device to the patient, toensure that the catheter is not prematurely removed. Although notnecessary for simple in-hospital thoracentesis as described in the work,a sturdy means of affixing the device to the patient is critical in theemergent arena (both in- and out-of-hospital), when the patient may beundergoing rapid transport and/or significant other movement, such asfrom concurrent Cardio-Pulmonary Resuscitation (CPR) or surgery.

Additionally, Turkel describes subsequent modifications in U.S. Pat. No.5,685,852, which is a similar Veress device modified for use as anepidural needle. This device has an indicator to allow visualization ofthe rotation of the needle, but if used for the treatment of tensionpneumothorax and/or hemothorax would have similar disadvantages asaforementioned.

U.S. Pat. No. 6,447,483 to Steube, et al is a Veress thoracentesisneedle similar to that of Turkel, with an improved hyper-sensitivedetection mechanism for sensing when the blunt portion of the Veress isin contact with the lung. For the emergency treatment of tensionpneumothorax and/or hemothorax, it has the same disadvantages asdescribed for Turkel.

Similar to Turkel and Steube, thoracentesis Veress-type needles with oneor more automatic check valves are available commercially. These includethe “Toramatic” devices (e.g. 1-55, 1-80, 1-VER) from Bioservice S.p.A.and Medax Medical Devices, “Safe-T-Centesis® Catheter Drainage System”from CareFusion, and the “Pleura-safe® Safety Thoracentesis Needle” fromAllomed Medtech GmbH. However, for the emergency treatment of tensionpneumothorax and/or hemothorax, these have the same disadvantages asalready described for Turkel and Steube.

Regardless of use, the Veress needle assemblies of the art have notbefore been modified specifically for the emergent treatment of tensionpneumothorax and/or hemothorax. Indeed, no Veress needle assembliesdescribed have been used with a stable documenter to indicate a positivediagnosis for tension. Additionally, no method has to date beendescribed for the safe treatment of tension pneumothorax and/orhemothorax using a device that simultaneously or near-simultaneouslystably documents and treats the life-threatening process, with minimalrisk to misdiagnosed patients. As such, there is a need for an emergencydevice and method to do so.

Each of the patents and published patent applications mentioned aboveare hereby incorporated by reference.

SUMMARY OF THE INVENTION

The present invention overcomes and substantially alleviates thedeficiencies in the prior art by providing a method and device tosimultaneously or near-simultaneously document and treat tensionpneumothorax and/or hemothorax.

A primary object of the invention is to provide a method of simultaneousor near-simultaneous documentation and treatment of tension pneumothoraxand/or hemothorax. Due to increased safety precautions that result inlessened risk to patients, this method provides an improved diagnosticand treatment means in high-risk patient populations.

Another object of the invention is to provide a method for empirictreatment based on at risk population characteristics, rather thansolely depending on classic physical findings or delayed diagnosticmeans. This is possible with the use of the device described herein,which lessens the risks of injury to healthy lungs and documents theneed (or lack thereof) for further follow-up treatment, such that inspecific populations the potential benefits of rapid insertion outweighthe risks. For example, further research may identify soldiers in shockor sudden arrest wounded from penetrating thoracic trauma, patients withsudden cardiac arrest while being mechanically ventilated, patientsundergoing cardiopulmonary resuscitation, and/or other groups as havingbenefit from immediate empiric insertion of device(s) to simultaneouslyor near-simultaneously document and treat possible tension pneumothoraxand/or hemothorax, while risking only minimal chance of injury tohealthy lungs if use is overly sensitive but less specific. As opposedto current common practice, this method may include bilateral use ofsaid device(s).

Another object of the invention is to provide a method that is animprovement upon current art because it reliably documents successfultreatment even for patients who have already been diagnosed with tensionpneumothorax and/or hemothorax (e.g. by chest x-ray, ultrasound,computerized tomography, etc.). The documentation means allows forimmediate confirmation of the successful treatment of tension buildup.

Another object of the present invention is to provide a device by whichemergency personnel can rapidly document and treat tension pneumothoraxand/or hemothorax, while introducing minimal risk of complications, suchas lung or heart injury, open pneumothorax, and/or the need for unneededfurther procedures. If employed on a patient who was misdiagnosed, theVeress-type needle reduces the chance of iatrogenic vital organ injury,check valve inhibits the introduction of iatrogenic pneumothorax, andpressure indicator documents the need for further procedures (e.g.thoracostomy).

Another object of the present invention is to provide a device foreasily treating and documenting tension pneumothorax and/or hemothoraxthat can be used by out-of-hospital personnel with minimal experienceand training, including under battlefield and mass casualty conditions.

Another object of the invention is to provide a sterile diagnosis andtreatment device for the treatment of tension pneumothorax and/orhemothorax that can be efficiently packaged, stored, and carried intoareas and situations that do not have access to standard diagnosticmeans (e.g. rapid x-ray or ultrasound).

Another object of the invention is to provide a device for documentingand treating tension pneumothorax and/or hemothorax that has a lumenwhich will not kink or be easily sealed during patient transport,thereby preventing occult tension pneumothorax.

Another object of the present invention is to provide a device forquickly and easily documenting and treating tension pneumothorax and/orhemothorax that can be used by in-hospital personnel, to provide forimmediate diagnosis and stabilization until definitive treatment (e.g.thoracostomy) can be performed.

Another object of the present invention is to provide a disposablemedical pressure gauge device which is simple and inexpensive inconstruction, efficient in operation, easy to manufacture and assemble,and that visually documents the current or past positive pressure withina cavity (e.g. the pleural cavity) of a patient.

Another object of the present invention is to provide a Veress-typeneedle assembly having a needle with a sharp end and a forwardly biasedconcentric probe with a blunt end, where the blunt end of the probeextends past the sharp end of the needle when no or minimal force isapplied to the blunt end of the probe.

Another object of the invention is to provide a device that assists theuser in determining and/or halting forward movement of a needle and/orprobe upon penetration into a body cavity (i.e. pleural space).

Another object of the invention is to provide a device for documentingand treating tension pneumothorax and/or hemothorax that can be quicklyand easily secured to a patient, so as to free the hands of medicalpersonnel treating the condition and to prevent dislodgement.

Another object of the invention is to provide a device and method thatcan be used for the prevention and/or treatment of tension pneumothoraxand/or hemothorax in high-risk patients, for example specific patientsundergoing hyperbaric treatment, other changes in environmental pressure(e.g. helicopter transport, plane flight), or specific procedures (e.g.bronchoscopy or lung biopsy).

These and other objects of the invention are achieved by providing atension pneumothorax and/or hemothorax treatment device having aVeress-type needle assembly, automatic check valve, and pressureindicator. In one embodiment, the Veress needle is composed of alongitudinally extending hollow needle which is sharp at its distal endto allow for puncturing the chest wall and extending into the pleuralcavity, a longitudinally extending hollow probe which extends throughthe hollow needle and has a blunt distal end with one or more openings,a spring which is coupled to the probe and which resiliently biases theprobe forward with respect to the hollow needle such that the bluntdistal end of the probe extends past the sharp distal end of the needle,and a hollow housing which is fixed to the needle and which houses thespring and permits relative movement of the probe relative to thehousing. The Veress needle section is fashioned such that it creates apath to an automatic check valve that permits flow of air and/or fluidonly in a proximal direction. The connected Veress needle and automaticcheck valve are adapted to transmit the pressure of air and/or fluidwithin the pleural cavity to the interior surface of the pressureindicator, such that if a pressure greater than environmental (e.g.atmospheric) pressure is present, the pressure indicator will be urgedproximally to lock in a proximal configuration. This allows the airand/or fluid to escape from the plural space through the device and intothe external environment, thus immediately treating the tensionpneumothorax and/or hemothorax. Additionally, this simultaneously, ornear-simultaneously provides a stable indicator to be viewed by currentand/or later medical personnel to positively document the diagnosis ofcurrent or previous increased pressure within the pleural cavity, thusindicating the likely need for further definitive treatment. If thepressure indicator does not move proximally, atmospheric pressure orless exists within the pleural cavity, thus indicating to current andlater medical personnel the lack of a tension pneumothorax and/orhemothorax and the need to search for other causes for patientdecomposition. The device can also include means for affixing the deviceto a patient and/or means for assisting the user in determining and/orhalting forward movement upon penetration into a body cavity (i.e.pleural space). Thus, the provided assembly substantially reduces thepossibility of iatrogenic lung puncture, automatically prevents thepossibility of iatrogenic introduction of air into the pleural space,and allows for the simultaneous diagnosis and treatment of tensionpneumothorax and/or hemothorax.

In one embodiment, the device may be inexpensively manufactured and isdesigned to be disposed of after one use. The Veress needle ispreferably made of metal, such as stainless steel. The probe may be madeof metal or plastic or other suitable material. The device housing andhandle are made of rigid plastic. The device housing may be made ofseveral parts which are joined together after the internal componentsare placed in the housing. The needle and/or catheter can be composed ofa radio-opaque material and/or contain radio-opaque markers.

In one embodiment, the device also includes at least one means forsecuring the full device to a patient, such as by tape, glue, suture, orother means. A securing means can include a disk through which theneedle projects that in practice is placed flush to the patient's skin.The disk can then be taped, sutured, stapled or otherwise adhered ontothe patient. In another embodiment, the distal side (touching thepatient's skin) of the disk is coated with a skin adhesive, so that thedisk, and thus the full device, can be adhesively attached to thepatient. Prior to use, the adhesive side of the disk is coated by aremovable covering which does not affect the integrity of the adhesivewhen removed.

In one embodiment, there are different sizes of devices for differentsubgroups of patients (e.g. based on age, gender, weight, and/orlength). These may come together in a kit, with means for determiningproper sizing. For example, radiologic studies done by Harke et al. showmean chest wall thickness of deployed soldiers to be 5.36 cm, leading toa recommendation of 8 cm angiocatheter for needle decompression amongadult males. It is advantageous to have differently sized devices fordifferent subgroups, so long as the needle is of sufficient length topuncture the chest wall and extend into the pleural cavity, but notoverly long to increase the risk of lung or heart injury. Theappropriately sized device can be chosen for different subgroups basedon weight, age, gender, length, pre-determined size categories (e.g.Broselow scale), and/or other indicators.

In one embodiment, the device includes one or more coupling matingmeans, such as luer or suction tubing coupling, which can be placed atthe proximal end or near proximal end of the device. This allows thedevice to be reversibly hooked up to a syringe and/or suction system, soas to drain air and/or fluid through the device under negative pressure.This also may allow means to hook up the device to a three-way stopcock,which could alternatively be fully and irreversibly incorporated intothe needle assembly.

In another embodiment of the present invention, the means for securingthe device to the patient and/or the housing is adjustable, such thatone device can be used on different patient groups (e.g. age, gender,weight, length, Broselow category). Under this embodiment, the devicecan be adjusted prior to (or alternatively during or after) insertion,such that the securing and/or housing means moves relative to theVeress-type needle to provide the desired exposed needle length for aspecific patient (i.e. smaller exposed needle lengths for patients withsmaller chest wall thicknesses; larger for patients with larger chestwall thicknesses). By way of example, this could be done via a slidinggripping stopper, twisting screw, tabs and notches, or other mechanism.The device can contain a means for setting this length based upon one ormore pre-determined patient groups (e.g. age, gender, weight, length,Broselow category), which are indicated on the device. The needle mayadditionally have distance (e.g. centimeter) markings along its externallength for easy measurement of depth.

In yet another embodiment of the present invention, the automatic checkvalve and pressure indicator mechanisms are fully and/or partiallycombined, so as to minimize parts and/or manufacturing cost. Under thisembodiment, the device is formed such that the initial opening of theautomatic check valve serves to provide stable documentary evidence ofprevious or current increased pressure within the pleural cavity, thusindicating the likely need for further definitive treatment whileallowing air and/or fluid to immediately escape from the pleural spacethrough the device and into the external environment.

In yet another embodiment, the Veress-needle assembly provides visualand/or audible signals to a practitioner when the pleural cavity hasbeen reached and/or indicates to the user if the blunt tip distal end ofthe inner needle has made contact with the lung. This mechanism may bestandard (using one spring) or more sensitive (using two or more), inmanners similarly disclosed in U.S. Pat. No. 5,334,159 to Turkel and/orU.S. Pat. No. 6,447,483 to Steube et al which are hereby incorporated byreference herein.

In yet another embodiment, the device includes a means for automaticallyhalting the forward movement of the device upon penetration into a bodycavity (e.g. pleural space). In one embodiment of this mechanism, theexternal movement of the Veress-probe in relation to the needle tipduring use causes movement of the probe within the housing such that anexternal stabilizer that is flush with the patients skin can move inrelation to the rest of the device only when the probe tip is in theproximal position in relation to the needle tip (e.g. penetrating chestwall) and will not move when the probe is in the extended distalposition (e.g. in the pleural cavity). This mechanism automaticallyprevents the user from penetrating the device too far into the bodycavity and thus injuring vital organs or other structures.

In yet another embodiment, the device includes a catheter (which caninclude a check valve) over the Veress-needle that can remain within thepatient, if the pressure documenter indicates that there is or wastension, which may be in a manner similarly disclosed in U.S. Pat. No.7,229,433 to Mullen which is hereby incorporated by reference herein. Inthis embodiment, there is the option of a second step where the rest ofthe device is removed from the patient leaving the catheter within thechest cavity.

In yet another embodiment, the device comprises initially separatestabilization means, Veress-type needle device, and pressure documentermeans that can be reversibly combined. In different embodiments, both oreither of the Veress needle and pressure documenter have an automaticcheck valve. These sections can be combined into one device prior to useon a patient.

In yet another embodiment, other means for the indication of pressureare employed to stably document the presence of tension (increasedpressure) before, during, or shortly after its release. For example,under one embodiment the pressure indicator is a liquid column (e.g.sterile water, normal saline, or other suitable liquid). Such liquid maybe colored (e.g. with green dye) such that is easily visible or othermeans for more easily viewing the liquid may be employed (e.g. shinymetallic flakes). When tension is present, pressure forces the liquidout of the device or into another chamber such as to indicate stably thediagnosis. Under various embodiments the pressure indicator is anothertype of piston mechanisms (e.g. movable ball valve); a burst disk; abourdon or other aneroid type gauge; a folded or otherwise coiled tubeor balloon, such that pressure causes uncoiling and/or release; anelectronic sensor (e.g. a piezoresistive strain, capacitive,electromagnetic, piezoelectric, optical, potentiometric, resonant,thermal, or ionizing sensor); an optical or other type of sensor thatdirectly senses the opening of the check valve; or any other type offorce collector (e.g. diaphragm, piston, bourdon tube, bellows) thatmeasures strain or deflection due to applied force over an area.

In yet another embodiment, the device and method includes a means formeasuring and/or viewing negative pressure, in addition to stablydocumenting increased pressure (i.e. tension). Under this embodiment,the pressure documenter portion of the device can show negativepressure, indicating that the device has entered a healthy pleural spacewithout tension in a patient breathing spontaneously. This may beachieved via any of the aforementioned means for sensing pressure, othermechanical means, or via electronic means in a manner similarlydisclosed in U.S. Pat. No. 5,421,821 to Janicki et al that is herebyincorporated by reference herein.

In yet another embodiment, the device includes a means for protectingthe user from a needle stick injury when removing the device from thepatient. Under this embodiment, such means can be arranged from any oneof the many self-blunting needle mechanisms for intravenous catheters orphlebotomy needles that are well known in the art. This mechanism mayinvolve the locking of the probe in its distally extended “blunt”configuration.

In yet another embodiment, the method includes the insertion(s) of thedevice of the present invention prior to the development of tensionpneumothorax and/or hemothorax, to prevent and document the dangerousdevelopment of tension. Under this embodiment, identified high-riskpatients would have the device inserted unilaterally or bilaterallyprior to high-risk activities, such as hyperbaric treatment, otherchanges in environmental pressure (e.g. helicopter transport, planeflight), or specific procedures (e.g. bronchoscopy and/or lung biopsy).

There have been illustrated and described herein methods and devices tosimultaneously or near-simultaneously document and treat tensionpneumothorax and/or hemothorax. While particular embodiments of theinvention have been described, it is not intended that the invention belimited thereto, as it is intended that the invention be as broad inscope as the art will allow and that the specification be read likewise.

From the foregoing, it can be seen that the present invention providesan effective means for treating tension pneumothorax and/or hemothoraxwithin animals, especially humans. Moreover, it should also be apparentthat the device can be made in varying lengths and sizes to treatadults, children, and infants. While the invention has been describedwith a certain degree of particularity, it is manifest that many changesmay be made in the details of construction and the arrangement ofcomponents without departing from the spirit and scope of thisdisclosure. It is understood that the invention is not limited to theembodiments set forth herein for purposes of exemplification and thatelements of certain embodiments can be combined with elements of otherembodiments. Additional objects, advantages, and novel features of theinvention will be set forth in the description which follows, and willbecome apparent to those skilled in the art upon examination of thefollowing detailed description and figures. It should be understood thatnot all of the features described need be incorporated into a givenmethod or device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of the method according to an embodiment ofthe invention for the simultaneous or near-simultaneous documentationand treatment of tension pneumothorax and/or hemothorax.

FIG. 2 is a block diagram of the method according to an embodiment ofthe invention for the simultaneous or near-simultaneous documentationand treatment of tension pneumothorax and/or hemothorax.

FIG. 3 is a perspective view of a tension treatment device of thepresent invention in accordance with one embodiment, as assembled priorto use.

FIG. 4 is a cross section view of a tension treatment device of thepresent invention in accordance with one embodiment, as assembled priorto use.

FIG. 5 is a detailed cross section view of the proximal components of atension treatment device of the present invention in accordance with oneembodiment, as assembled prior to use.

FIG. 6 is an expanded perspective view of a tension treatment device ofthe present invention in accordance with one embodiment, shown in anexpanded view before assembly.

FIG. 7 is a cross-sectional side view of a tension treatment device ofthe present invention in accordance with one embodiment, shown asassembled prior to insertion into the chest cavity.

FIG. 8 is a cross-sectional side view of the tension treatment device ofFIG. 7, shown upon contact with the skin.

FIG. 9 is a cross-sectional side view of the tension treatment device ofFIG. 7, shown upon first penetration of the chest wall.

FIG. 10 is a cross-sectional side view of the tension treatment deviceof FIG. 7, shown upon entrance into the pleural space when there was notension present.

FIG. 11 is a cross-sectional side view of the tension treatment deviceof FIG. 7, shown upon entrance into the pleural space when there wastension present.

FIG. 12 is a perspective view of a tension treatment device of thepresent invention in accordance with one embodiment, as assembled priorto use.

FIG. 13 is a cross section view of a tension treatment device of thepresent invention in accordance with one embodiment, as assembled priorto use.

FIG. 14 is a perspective view of a tension treatment device of thepresent invention in accordance with one embodiment, as assembled priorto use.

FIG. 15 is a cross section view of a tension treatment device of thepresent invention in accordance with one embodiment, as assembled priorto use.

FIG. 16 is a cross-sectional side view of a tension treatment device ofthe present invention in accordance with one embodiment, shown asassembled prior to insertion into a body cavity.

FIG. 17 is a cross-sectional side view of the tension treatment deviceof FIG. 16, shown upon penetration of the cavity wall (e.g. chest wall).

FIG. 18 is a cross-sectional side view of the tension treatment deviceof FIG. 16, shown upon entrance into the body cavity when there wastension present.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawings, FIG. 1 generally shows the one embodiment ofa method and workflow 300 for the treatment of tension pneumothoraxand/or hemothorax. This method and workflow of the present invention 300should be assumed to fit within standard emergency care protocol wellknown in the art (and not described here), which may also be assumed tobe occurring previous, after, and potentially parallel throughout,especially when there is more than one practitioner caring for aparticular patient. Additionally, methods of standard needle use,patient cleaning, equipment disposal, and other standard medicalpractice well known in the art are not described here.

First, an out-of-hospital or in-hospital practitioner performs a rapidand low-cost assessment to decide if a patient meets pre-determined riskgroup criteria at step 301. As aforementioned, these risk group criteriacan be a combination of signs, symptoms, and/or risk factors and are notdescribed in detail here.

If the result of the assessment 301 is negative, there is no deploymentof the intervention and standard practice ensues at step 310 (notexplained in detail here). The patient may continue to repeatedly beassessed for risk group criteria as shown by loop 312 and, if thepatient's condition evolves to meet such criteria the workflow restartsat assessment point 301.

If the assessment result 301 is positive for meeting risk groupcriteria, bilateral implementation of device(s) ensues at step 320. Thisis followed by the simultaneous or near-simultaneous documentation andtreatment of tension pneumothorax and/or hemothorax at step 330 ifpresent in the patient. This may be performed with two devices or,alternatively, with one device used on both sides in cases where thefirst side is negative for tension and device cost is a significantconcern.

If step 330 does not document tension, then the device is removed atstep 340 either by the primary user or by a later higher level of care(e.g. after transport or the arrival of more qualified medicalpersonnel). If device removal 340 is not to be immediate, the device canbe secured to the patient to prevent inadvertent removal and/ormovement.

If step 330 does document tension, then the device is maintained at step350. The device may be secured to the patient at this time to preventinadvertent removal and/or movement. Standard care can then be resumedor focused on, as it may have been occurring parallel throughout themethod and workflow 300 of the present invention.

After step 350, definitive care next ensues at 360 on the side(s)documented as positive for tension. Definitive care 360 is mostfrequently a tube thoracostomy, but encompasses any type of definitivecare for tension pneumothorax and/or hemothorax (e.g. thoracotomy). Itshould be noted that longer-term maintenance and/or monitoring of theinserted device of the current invention may be sufficient fordefinitive care 360 (e.g. hooking up the device to suction). Definitivecare 360 may be performed by the primary user or by a later higher levelof care (e.g. after transport or the arrival of more qualifiedpersonnel). Standard care (not described here) then continues.

FIG. 2 generally shows another embodiment of the method and workflow 300for the treatment of tension pneumothorax and/or hemothorax under thepresent invention. In this embodiment, after assessment step 301, thereis inserted a step for checking for lateralizing indicator(s) 302. Thismay be performed by auscultation, ultrasound, or other rapid means thathelp identify the side of the possible tension pneumothorax and/orhemothorax, if such is present only on one side.

A practitioner may enter the workflow at step 302 when there is apositive documentation of tension under step 330 after the placement ofthe first device (in what was going to be bilateral placement, butbefore the placement of the second device). A practitioner may enter theworkflow at step 302 having already confirmed, via standard diagnosticmeans (e.g. chest x-ray, computed tomography, ultrasound, or othermeans), the presence of a unilateral or bilateral tension pneumothoraxand/or hemothorax.

If such lateralizing indicator(s) 302 are not present, bilateralinsertion of device(s) ensues at step 320, along with the further stepsas previously outlined. This also occurs in the case of confirmedbilateral tension pneumothorax and/or hemothorax.

If such lateralizing symptoms 302 are present, unilateral insertionensues at step 304, in such side as presumed to have the tensionpneumothorax and/or hemothorax. Next, a check for positive documentationand clinical improvement is done at step 306. If the patient did nothave documented tension on that side or has not improved, then a deviceis placed on the other side for bilateral device implementation 320(except in cases where this has already been definitively ruled out). Ifthe patient had documented tension and improved with unilateralplacement, then no additional device is placed on the other side.Regardless, both paths result in the simultaneous documentation andtreatment of tension pneumothorax and/or hemothorax if present 330 onthe side(s) inserted. The further steps as previously outlined thenensue.

Moving now to FIGS. 3 and 4, one embodiment of a device of the presentinvention device is illustrated and generally indicated as 10. For easeof reference, distal shall refer to the end of the device farthest awayfrom the user, while proximal shall refer to the end of the deviceclosest to the user.

The device generally comprises a needle assembly 10 made up of severalparts, including: a longitudinally extending hollow needle 20, astabilization device 30, a hollow housing 40, a hollow probe 50, a probeholder 60, a spring 80, a cylinder 90, an automatic check valve 100, atension documenter 110 and a mating cap 130. Together, the needle 20,housing 40, probe 50, and spring 80 can function as a Veress-type needleassembly.

Turning to FIGS. 5 and 6 in conjunction with FIGS. 3 and 4, it is seenthat hollow needle 20 has a sharp distal end 22 and a proximal end 24.Hollow needle 20 is preferably molded into housing 40 such that theproximal end 24 of the needle is securely held in housing 40. Thus,housing 40 is provided with a passage 41 in which the needle is held.The needle 20 additionally passes through stabilizer 30.

Passage 41 opens up into an open interior of housing 40 that can includea cylindrical chamber 42 which is sized to receive other internalcomponents as discussed herein after. The outer surface of housing 40 ispreferably provided with abutment 43, ribs 45, and visual indicators 44and 46, as well as a proximal portion with grooves 47 and abutmentsurface 48. Ribs 45 are provided as finger grips, while abutment 43prevents the practitioner's hand from sliding off of housing 40.Proximal grooved portion 47 and abutment surface 48 provide a matingsurface for the distal portion of mating cap 130. Housing 40 may besufficiently transparent and have external visual indicators 44 and 46that can be used respectively as reference points to indicate when probeholder 60 (viewed within chamber 42) is in its distal or proximalposition and thus when connected probe 50 is extended or retracted.

The hollow probe 50 may be a standard Veress-type needle probe having ablunt distal end 52 with one or more ports or openings 54, and aproximal end 56. The opening(s) 54 in distal end 52 are provided topermit air and/or fluid to enter a generally hollow interior of probe 50from the body cavity entered (e.g., the pleural cavity). Probe 50 (withprobe holder 60 as discussed following) is inserted into chamber 42 andextends out through needle 20, such that (as seen in FIGS. 3 and 4) theblunt distal end 52 of probe 50 extends past the sharp distal end 22 ofthe needle 20. Proximal end 56 of probe 50 extends through spring 80 andinto orifice 92 of cylinder 90.

Probe holder 60 is can be plastic or metal and colored or otherwisemarked to make it easier for viewing within housing 40. It has an axialpassage 62 through which probe 50 extends axially in both directions.Holder 60 can be melded to probe 50 to hold it securely without movementbetween the two parts. Chamber 42 of housing 40 receives probe holder60, along with probe 50 (as previously mentioned). Probe holder 60 canbe fashioned such that its distal cylindrical segment 66 fits intocylinder 42 of housing 40 (i.e., the outer diameter of holder 60 is justslightly smaller than the inner diameter of chamber 42). The proximalend of holder 60 is preferably a frusto-conical segment 68 in shape,which fits inside spring 80, thus providing a seat and centeringmechanism.

Spring 80 provides a biasing mechanism or means for biasing for probe 50as transmitted through probe holder 60, with the distal end of spring 80resting on probe holder segment 68. The proximal end of spring 80 abutsdistal cylinder surface 96, with the proximal end 56 of probe 50extending through spring 80. While spring 80 is preferably a spring asis commonly known in the art, it should be appreciated that otherresilient biasing mechanisms could be otherwise utilized (e.g. a pieceof elastic or rubber with a hole for fluid communication).

Cylinder 90 can be formed of plastic and be a substantially hollowcylinder, including an opening 92 in its distal end through which theproximal end 56 of hollow probe 50 terminates within chamber 94; thediameter of opening 92 is preferably just slightly larger than the outerdiameter of proximal probe end 56, which can form an air-tight seal.Cylinder 90 also has distal end 96 which provides a housing and stop forspring 80. Spring 80 is thus held between the proximal segment 68 ofprobe holder 60 and the distal end 96 of cylinder 90, therebyeffectively acting to bias probe 50 in a distal position relative toneedle 20. Additionally, cylinder 90 has ledge 98 which provides a stopand connection mechanism for automatic check valve 100, such as toprovide an air-tight seal between check valve 100 and ledge 98. Thus,preferably no air is permitted to enter probe 50 to move in the distaldirection due to check valve 100 and seal(s) between proximal end 56,ledge 98, cylinder 90, housing 40, cap 130, and/or additional sealingmeans (e.g. O-ring(s)), depending on different embodiments. However, airand/or fluid may move proximally from within the hollow probe end 56 andout of chamber 94 through automatic check valve 100 and into mating cap130. Check valve 100 is therefore one example of a means for permittingfluid to flow proximally through the device while preventing fluid fromflowing distally through the device.

In one embodiment, automatic check valve 100 is a duck billed valve.However, it should be appreciated that numerous different types ofautomatic check valves could be utilized by those of standard knowledgeof the art. Valve 100 has a distal ring surface 102 which, as previouslymentioned, mates to form an air-tight seal with ledge 98 of cylinder 90.Air and/or fluid is able to move only in a proximal direction throughthe center of the valve 106. Check valve 100 also has a proximal ringsurface 104 upon which the distal surface 134 of mating cap 130 rests tominimize movement of valve 100 and assist in providing seal.

A pressure indicator such as tension documenter 110 can be made ofplastic with the color being red or another easily visible color.Tension documenter 110 fits within cap 130 such that the outer diameterof documenter 110 is just slightly smaller than the inner diameter ofchamber 136, allowing documenter 110 to slide proximally within chamber136 in order to function as a means for providing a stable visualindication of whether air has passed proximally through the device.Although ridge(s) 138 can allow documenter 110 to move in a proximaldirection, they can also prevent its movement in a distal direction onceit has passed proximally. Mating cap 130 generally comprises a hollowcylinder made of, for example, plastic, of which at least the proximalportion is transparent and/or has holes 139 to allow visualization ofdocumenter 110 when in its proximal position. The distal inner surfaceof mating cap 130 includes grooves 131 to match up with ridges 47, sothat cap 130 can mate with housing 40 (which is connected to needle 20and stabilizer 30) to secure the rest of the contents of device 10within. Cap 130 can be fixed to housing 40 by glue, sonic welding, orother means well known in the art. Finally, cap 130 includes opening(s)139 to provide an exit for air and/or fluid into the externalenvironment. These holes may be covered to minimize possible splashingof fluid into the eyes of the user. In other embodiments, cap 130 has aluer lock or other syringe fittings, ports, or connections to suctionand/or drainage tubing that can serve as the exit for air and/or fluidinto the external environment and/or provide the ability to hook updevice 10 to a syringe and/or suction. In such embodiments, device 10may also include a sealing cap that reversibly connects to theconnector(s).

Moving now to FIGS. 7-11, needle assembly 10 of an embodiment of theinvention is described in use. In FIG. 7, the assembly 10 is shownbefore insertion into the example of a human body with skin 142 coveringa chest wall 144 within which lies a pleural cavity 146 and lung 148.Probe holder 60 is in its distal position and tip 52 of probe 50 extendsout distally from the tip 22 of needle 20, due to the biasing actionfrom spring 80 on probe holder 60 and thus probe 50 as previouslydescribed. Additionally, tension documenter 110 within chamber 136 ofmating cap 130 is in its initial distal position, preferably lightlyheld there by slight tension with the walls of cavity 136; ridges 138;lubricant, liquid, or jelly; and/or other such means. Thus, the usercannot see the colored documenter 110 through holes 139 and withincavity 136, which alerts the user to the device being ready to use.

FIG. 8 demonstrates when probe end 52 first touches the skin 142. Thiscauses probe tip 52 to move proximally in reference to needle tip 22,and likewise probe 50 to move proximally in reference to needle 20 andhousing 40. As probe 50 is adhered to probe holder 60, this causesholder 60 to start to move proximally within cavity 42, thus compressingspring 80. Additionally, proximal probe end 56 starts to move withinchamber 94.

Moving now to FIG. 9, when needle 20 pierces skin 142 and starts toenter chest wall 144, it causes probe tip 52 to move further proximallyin reference to needle tip 22. Likewise, probe 50 moves furtherproximally in reference to housing 40, holder 60 moves furtherproximally within cavity 42, and proximal probe end 56 moves furtherproximally within chamber 94.

FIG. 10 demonstrates device 10 used with a patient without a tensionpneumothorax and/or hemothorax, who thus has a lower pressure in thepleural space 146 compared to the external environment outside opening139. Once needle 20 pierces chest wall 144 and enters pleural space 146,spring 80 acting upon holder 60 forces probe 50 to move distally inreference to housing 40 and needle 20, thus projecting probe tip 52distal to needle tip 22 and exposing probe opening(s) 54 within pleuralspace 146. Therefore, the extended blunt probe end 52 serves to protectlung 148 (or other vital structures) from the sharp distal needle tip22, providing one of the benefits of the current invention.

As probe opening(s) 54 are then exposed to pleural space 146, theyconnect the pleural space 146 to the proximal probe opening 56 throughhollow probe 50, forming one continuously open connected space. However,as long as the pressure in pleural space 146 is equal to or less thanthat of the external environment outside opening 139, check valve 100prevents air from entering chamber 94 and thus probe end 56, preventingthe introduction of air (i.e. an iatrogenic open pneumothorax) to thepatient. Additionally, if as in FIG. 10 there is no tension pneumothoraxand/or hemothorax in the pleural space 146 and thus lower pressure inthe pleural space 146 compared to the external environment outsideopening 139, there is no cause for movement of tension documenter 110.Thus, after insertion through the chest wall 144, the user can still notsee the colored documenter 110 within cavity 136 through hole 139, whichalerts current and later medical personnel that the patient did not havea tension pneumothorax and/or hemothorax on that lung side.

FIG. 11 demonstrates device 10 used with a patient who has a tensionpneumothorax and/or hemothorax, and thus has a higher pressure in thepleural space 146 compared to the external environment outside opening139. As shown by arrows 201, this increase pressure in pleural space 146is transmitted through probe opening 54 and flows through hollow probe50 to proximal probe opening 56 and into chamber 94. From there, therush of air and/or fluid passes through valve 100, as it is a higherpressure than the external environment, and into chamber 136. Withinchamber 136, the pressure propels mobile documenter 110 proximally,relative to cap 130, where it becomes locked proximally by ridges 138.This allows air and/or fluid that was trapped within the pleural space146 to exit via hole(s) 139 and into the external environment, thusrelieving the dangerous tension within the body. Check valve 100prevents any air from moving back distally. Additionally, coloreddocumenter 110 is now viewable through hole(s) 139 and within the(preferably transparent) proximal portion of cavity 136, which alertscurrent and later medical personnel that the patient had a tensionpneumothorax and/or hemothorax on that lung side and thus likelyrequires additional definitive care (e.g. tube thoracostomy).

The full device 10 may then be secured (not shown) to the patient andstabilized using stabilizer 30. In one embodiment, this is done byfurther inserting needle 20 until stabilizer 30 is flush with patient'sskin 142. Then, as by one of the many common means of adhering devicesto patient skin known in the art (e.g. tape, glue, suture, staples,etc.), with or without adhesive previously applied to stabilizer 30 thatcan then be exposed, the device is secured to the patient. Asaforementioned, in another embodiment of the present invention,stabilizing device 30 and/or housing 40 can be adjustable, such as toalter the full exposed length of the needle 20. This could either bedone after insertion and once through the chest wall 144, moving thestabilizer 30 to become flush with patient's skin 142, or prior toinsertion based on predicted chest wall thickness.

Moving now to FIGS. 12 and 13, another embodiment of a device 10 of thepresent invention device is illustrated. Under this embodiment, pressuredocumenter or indicator 110 that serves as a means for providing astable visual indication of whether air has passed proximally throughthe device is a liquid column (e.g. sterile water, normal saline, orother suitable liquid) that may be colored (e.g. with green dye) orotherwise made easier to see (e.g. containing shiny metallic flecks)such that is easily visible within chamber 133 of cap 130. Thisdocumenting liquid 110 can be pre-filled within chamber 133 throughcheck valve 100 to fill line 135, such that it is externally viewablethrough transparent walls 137 by the user(s). Check valve 100 keepsliquid documenter 110 within cavity 133 and surface tension with walls137 forces the liquid to remain at line 135. Preferably, a sealing cap(not shown) can be reversibly secured to the distal portion of matingcap 130 to further secure liquid documenter 110 in place duringpreparation, storage, and/or transport, which is then removed prior touse. Visualization of liquid documenter 110 within cavity 133 stablyindicates that air and/or blood has not yet exited the device; that thedevice is ready to use; and that tension was not present when placed ina patient. The absence of liquid documenter 110, which may be expelledby pressure from device 10, indicates that tension was present.

Moving now to FIGS. 14 and 15, another embodiment of device 10 of thepresent invention device is illustrated. Under this embodiment,stabilizer 30 initially extends distally from holder 40 along the tractof needle 20, to provide a mechanism for automatically halting theforward movement of needle tip 22 and probe tip 52 upon penetration intoa body cavity (e.g. pleural space). Stabilizer 30 is preferably held inplace by one or more rods 32, which extend and preferably lock into thejoint tunnel provided by cavities 36 and 38 of holder 40 and cap 130respectively. These cavities also hold spring 84 which pushes on rod(s)32 to bias stabilizer 30 distally, although it should be appreciatedthat other resilient biasing mechanisms could be otherwise utilized(e.g. a piece of elastic or rubber). Holder 40 additionally has one ormore phalanges 49 that are resiliently biased medially, but when pushedlaterally by probe holder 60 are caused to interact with grooves 34 onrods 32 so as to halt the movement of stabilizer 30 in respect to therest of device 10.

Moving now to FIGS. 16-18, one example mechanism for automaticallyhalting the forward movement of device 10 upon entrance to a body cavityis shown in use. FIG. 16 demonstrates the assembly 10 before insertioninto the example of a human body. Biased by spring 80, probe holder 60is in its distal position, which extends tip 52 of probe 50 out distallyfrom tip 22 of needle 20. Additionally, this pushes phalange(s) 49laterally to reversibly lock with grooves 34 and inhibit the movement ofrod(s) 32 and thus stabilizer 30 in relation to the rest of device 10.Additionally, liquid documenter 110 is present within chamber 136 ofmating cap 130, which alerts the user to the device being ready to use.

FIG. 17 demonstrates when needle 20 pierces skin 142 and chest wall 144,which causes probe tip 52 to move proximally in reference to needle tip22. This causes holder 60 on probe 50 to also move proximally inreference to housing 40. This in turn allows phalanges 49, which arebiased medially either through their innate structural design or byother means (e.g. rubber band, spring), to move medially and thus unlockfrom groove(s) 34 to allow rod 32 and thus stabilizer 30 to move inrelation to the rest of device 10. Spring 84 causes stabilizer 30 to beflush with skin 142. Thus, when a general distal biasing of device 10 isprovided by the user holding the device (or less preferably by anautomatic device mechanism, such as a spring, motor, or elastic band),stabilizer 30 remains flush with skin 142 while the rest of device 10moves distally, thus inserting needle 20 further into chest wall 142.

FIG. 18 demonstrates device 10 once probe tip 52 and needle tip 22 havereached a body cavity (e.g. in this illustration pleural space 146)which is under tension. Once needle tip 22 enters pleural space 146,spring 80 moves holder 60 distally in reference to housing 40 thusforcing phalange(s) laterally to lock with grooves 34 and inhibit themovement of rod(s) 32 and thus stabilizer 30 in relation to the rest ofdevice 10. This, in turn, prevents needle tip 22 and probe tip 52 frommoving further into pleural space 146, thus minimizing the chances ofinjuring vital structures and moving opening 54 out of the desired bodycavity. Under this embodiment, there is an air-tight seal between probeend 56 and cylinder hole 92, which may include the use of an O-ring orother sealing mechanisms. As the pleural cavity 146 was under tension,there is no liquid documenter 110 present within chamber 136 of matingcap 130 as it was expelled when air left the device through opening 139,which stably alerts the current and future user that the patient hadtension and may require further care.

There have been illustrated and described herein needle assemblies forthe diagnosis and treatment of tension pneumothorax and/or hemothorax.While particular embodiments of the invention have been described, it isnot intended that the invention be limited thereto, as it is intendedthat the invention be as broad in scope as the art will allow and thatthe specification be read likewise.

Thus, for example, while a spring 80 was disclosed as providing abiasing mechanism for the probe, it will be appreciated that otherresilient biasing mechanisms could be utilized. For example, a piece ofelastic or rubber (with a hole for fluid communication) could beextended over the rear of the probe and be anchored at a more distallocation to provide the forward biasing for the probe. It will beappreciated by those skilled in the art that such use may require simpleadjustments to the structure of housing 40, probe 50, holder 60, and/orcylinder 90.

Additionally, while a duck bill valve was described as one embodiment ofautomatic check valve 100, it will be appreciated that other automaticcheck valves could be utilized, including a flapper check valve, ball insocket check valve, umbrella check valve, v-tip needle check valve,and/or other automatic check valve. Additionally, more than one checkvalve may be utilized. It will be appreciated by those skilled in theart that such use may require simple adjustments to the structure ofhousing 40, probe 50, holder 60, cylinder 90, documenter 110, and/ormating cap 130. It will also be appreciated that in lieu of an automaticcheck valve, an automatic valve having a pressure threshold could beutilized.

Additionally, while a check valve 100 was described as distal todocumenter 110, it will be appreciated that this order could be reversedand/or more than one valve could be utilized. It will be appreciated bythose skilled in the art that such use may require simple adjustments tothe structure of housing 40, probe 50, holder 60, cylinder 90, valve100, documenter 110, and/or mating cap 130.

Additionally, while a particular mechanism of using cavity 136 and/orridges 138 was described as an embodiment for securing documenter 110 isin its initial distal position within cap 130 and preventing its returnonce deployed, it will be appreciated that other mechanisms could beutilized. In other embodiments, such means include other arrangements ofone or more ridges 138, resilient biasing methods such as a spring,other tapering or molding of the inner wall of cavity 136, a pressurevalve, slots, locking mechanisms, and/or other means to achieve suchgoal. Additionally, under different embodiments such means may bearranged to provide various degrees of pressure needed to movedocumenter 110 proximally (e.g. near minimal pressure above the externalenvironment, slight pressure, increased pressure) as determined mostbeneficial for function. It will be appreciated by those skilled in theart that such use may require simple adjustments to the structure ofcylinder 90, valve 100, documenter 110, and/or mating cap 130.

Additionally, while a particular documenter mechanism 110 was describedfor providing a visual documentation as to the presence of tension, itwill be appreciated that other mechanisms for providing a visualindication could be utilized. The documenter could be of other materialsand shapes, could be more distal or proximal within the housingarrangement, and could be viewed through a visually opaque material orpartially exposed, among other changes. It will be appreciated by thoseskilled in the art that such use may require simple adjustments toneedle assembly 10.

Additionally, while documenter mechanism 110 was disclosed as providinga mechanism for stably documenting the presence of increased pressure,it will be appreciated that any type of relief valve or other mechanismthat provides stable documentation of a release of pressure could beutilized. For example, documenter 110 may be more than one color (e.g.green and red) so as to provide a visual indicator of both a lack oftension (e.g. green) in addition to positive tension (e.g. red)depending on its position. Under related embodiments, indicator 110 maybe forced to move in a direction not directly in line with the force ofthe releasing pressure (e.g. perpendicular). It will be appreciated bythose skilled in the art that such use may require simple adjustments toneedle assembly 10.

Furthermore, it will be appreciated by those skilled in the art thatwalls of cap 130 can be all or partially transparent; in other shapesand material; could have other holes or slots; or could have no directexternal holes. Additionally, cap 130 may have a luer lock, othersyringe fittings, ports, 3-way stopcock, or connections to suctionand/or drainage tubing that can serve as the exit for air and/or fluidand/or provide the ability to hook up device 10 to a syringe, suction,and/or other types of drains or tubing. It will be appreciated by thoseskilled in the art that such use may require simple adjustments tomating cap 130.

Furthermore, it will be appreciated by those skilled in the art that theopening(s) 54 in the distal end 52 of the probe can be arranged indifferent arrangements so as to best achieves the results hereindesired. There may be one, two, three, or more openings, which can bearranged in parallel, staggered, or other fashion and may or may notinclude a partial or full opening at the most distal tip. These may bearranged as radial slots which are parallel the longitudinal axis of theprobe 50, on opposite sides of the probe 50 to be offset longitudinally,or as otherwise arranged. Additionally, in an alternative embodimentneedle 20 may also have additional distal openings to facilitate flow ofair and/or fluid.

Furthermore, it will be appreciated by those skilled in the art thatwhile a particular mechanism was described for automatically halting theforward movement of the device upon penetration into a body cavity (e.g.pleural space), other mechanisms could be utilized. This includes othermechanisms that use the movement of probe 50 in relation to needle 20,as well as mechanisms that do not utilize this movement (e.g. amechanical clutch-based needle insertion device). Other embodimentsinclude mechanisms so that rod(s) 32 within cavities 36 and 38 can onlymove one-way; to lock rod(s) 32 (and probe tip 52) in place beforestart, once reaching the desired cavity to prevent dislodgement, and/orafter use to prevent needle sticks; and other arrangements so as to bestachieves the results herein desired. Additionally, phalange(s) 49 may beseparate part(s) (e.g. made plastic, rubber, metal, or other desiredmaterial); may come directly off of probe holder 60 or probe 50 so asonly to deploy when in the distal position; may be a string and pulleysystem affixed within holder 40; or may be any other system thatreversibly locks stabilizer 30 in place when the probe 50 is more distalin comparison to housing 40. Rod(s) 32 may have other types of grooves34 or mechanisms to reversibly lock with phalanges 49. Additionally,rod(s) 32 may be medially located in reference to phalange(s) 49, sothat the mechanism is reversed and that an adjusted probe holder 60could provide medial pressure to phalange(s) 49 to cause a reversiblelocking with grooves 32.

Furthermore, it will be appreciated by those skilled in the art thatwhile a particular body cavity (i.e. pleural space) was described, thedevice and/or mechanism for automatically halting the forward movementof the device upon penetration into a body cavity can be used on othertypes of potential spaces and body cavities. Examples include theabdominal cavity, trachea, skull and other bones, vessels, bladder andother hollow organs, as well as abscesses and other collections of fluid(e.g. empyema, ascites, and pleural and other effusions).

Furthermore, it will be appreciated by those skilled in the art that theneedle assembly 10 of the invention may be used in conjunction with oneor more springs and/or resiliently biasing mechanisms, so as to providea hyper-sensitive detection mechanism to detect the lung, in a mannersimilar disclosed in U.S. Pat. No. 6,447,483 to Steube, et al which ishereby incorporated by reference herein.

Furthermore, it will be appreciated by those skilled in the art thatneedle assembly 10 of the invention may be used in conjunction with acatheter, in a manner similar to those disclosed in U.S. Pat. No.7,229,433 to Mullen, which is hereby incorporated by reference herein. Aflexible catheter, with or without an automatic check valve, could beincluded over needle 20, so that the catheter could remain in thepatient if so desired upon removal of the rest of the needle assembly.This catheter could be similar to a standard catheter, Penrose drain,pigtail catheter, chest tube, tracheostomy tube, endotracheal tube,venous or arterial catheter, thoracentesis tube, paracentesis tube,abscess drainage or other medical tube or catheter for placement into abody cavity.

Furthermore, it will be appreciated by those skilled in the art thatneedle assembly 10 of the invention may be used in conjunction with astent and/or otherwise expandable tubing or catheter, which may bereversibly or non-reversibly expanded by balloon or other mechanism.Once entering the desired body cavity with the needle assembly 10, thisballoon, stent, and/or tubing may serve to push tissue away from needle20 and/or once expanded function as a standard catheter, Penrose drain,pigtail catheter, chest tube, tracheostomy tube, endotracheal tube,venous or arterial catheter, thoracentesis tube, paracentesis tube,abscess drainage or other medical tube or catheter for placement into abody cavity.

Furthermore, it will be appreciated by those skilled in the art thatneedle assembly 10 of the invention with simple adjustments may be usedfor thoracentesis; thoracostomy; paracentesis; arthrocentesis;tracheostomy; laparoscopy; laparotomy; lumbar puncture;cricothyroidotomy; abscess drainage and/or empyema drainage; centralvenous catheter, peripheral venous catheter, arterial catheterplacement; ventriculostomy; or any medical procedure draining air and/orfluid and/or placing a catheter into a body cavity, hollow organ,vessel, and/or potential space.

Furthermore, while parts of embodiments of the needle assembly weredescribed as having certain shapes, and being made of certain materials,it will be appreciated that other materials and shapes can be utilized.It will therefore be appreciated by those skilled in the art that yetother modifications could be made to the provided invention withoutdeviating from its spirit and scope as so claimed.

The following references are hereby incorporated by reference: Mabry etal. “Prehospital advances in the management of severe penetratingtrauma.” Crit Care Med 2008 Vol. 36, No. 7 (Suppl.); (Harke H T, PearseL A, Levy A D, et al.: Chest wall thickness in military personnel:Implications for thoracentesis in tension pneumothorax. Mil Med 2007;172:12:1260-1263); Leigh-Smith et al. “Tension pneumothorax—time for are-think?” Emerg Med J 2005; “Tactical Combat Casualty Care Guidelines.”Military Health System. U.S. Department of Defense. 8 Aug. 2011; BassettE D et al. “Design of a Mechanical Clutch-Based Needle-InsertionDevice.” PNAS Early Edition. Aug. 25, 2008.www.pnas.org/cgi/doi/10.1073/pnas.0808274106; and Maxwell W B. “TheHanging Drop to Locate the Pleural Space: A Safer Method forDecompression of Suspected Tension Pneumothorax?” The Journal of Trauma,Injury, Infection, and Critical Care. October 2010.

The invention claimed is:
 1. A method for inserting a needle assemblyinto a body cavity of a patient, the needle assembly including agenerally hollow needle having a sharp distal end and a probe having ablunt distal end slidably disposed within the generally hollow needle,the blunt distal end of the probe being biased into a position distal tothe sharp distal end, the method comprising: engaging the blunt distalend of the probe with the skin and/or other tissue of the patient toovercome the bias to move the probe proximally relative to the hollowneedle to cause the sharp distal end of the hollow needle to pierce theskin and/or other tissue of the patient; inserting the generally hollowneedle into a body cavity of the patient; causing the generally hollowneedle to automatically halt distal movement into the body cavity uponentry of a distal portion of the generally hollow needle into the bodycavity, wherein the generally hollow needle automatically halts movingdistally into the body cavity upon entry into the body cavity due to theblunt distal end of the probe returning to the position distal to thesharp distal end of the hollow needle upon entry into the body cavity.2. The method of claim 1, wherein the probe, when in the distally biasedposition relative to the generally hollow needle, causes a stabilizerconfigured to stabilize on the skin of the patient to be non-mobilerelative to the housing.
 3. The method of claim 1, further comprisinginserting a catheter into the patient generally simultaneously with thegenerally hollow needle.
 4. The method of claim 1, wherein inserting thegenerally hollow needle causes a catheter over the generally hollowneedle to be inserted into the patient, and further comprising leavingthe catheter in the patient and removing the generally hollow needle. 5.The method of claim 1, wherein an expandable tubing is disposed over thegenerally hollow needle.
 6. The method of claim 1, wherein a flow pathis formed through the needle assembly, the flow path connecting the bodycavity to an external environment.
 7. The method of claim 6, wherein theflow path allows for only one-way direction of flow of gas and/or fluid.8. The method of claim 6, wherein a pressure indicator providesindication of whether gas and/or fluid has passed through the needleassembly.
 9. The method of claim 6, wherein gas and/or fluid is releasedthrough the needle assembly to connect the body cavity to the externalenvironment.
 10. The method of claim 1, wherein the method generallysimultaneously treats and documents tension pneumothorax and/orhemothorax.
 11. The method of claim 1, further comprising stabilizingthe needle assembly against the patient's skin after inserting theneedle assembly into the patient.